Evaluating the Impact of a Culinary Coaching Tele-medicine Program

NCT ID: NCT03823469

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2022-09-19

Brief Summary

Introduction: Obesity is a major public health problem and adopting healthy lifestyle habits, while effective, is challenging in real-world settings. Culinary coaching is a behavioral intervention that aims to improve nutrition and overall health by facilitating home cooking through an active learning process that combines culinary training and health coaching. Our goal is to evaluate whether a culinary coaching telemedicine program (twelve 30-minute sessions) will significantly improve outcomes among subjects with overweight or obesity.

General hypothesis: A culinary coaching telemedicine program will result in significant weight loss, and improvement in culinary attitude and self-efficacy, nutritional intake, and metabolic outcomes.

Methods: This is a two-site, 36-month randomized controlled trial in which study participants between the ages of 25 to 70, with 27.5 ≤ BMI ≤ 35 Kg/m2 will be randomly assigned to nutritional counseling combined with a structured culinary coaching program or to nutritional counseling group (18 intervention, 18 control at each site). Intervention will include a 3-month culinary coaching telemedicine program with outcome data collected periodically for 12 months. The pre-defined primary outcome is body weight loss at 6 months, and secondary outcomes include change in body weight and composition at 1 year, as well as culinary attitudes and self-efficacy through a validated questionnaire, nutritional intake, lipid profile, blood pressure, and HgA1c (glycated hemoglobin); and participants' perception of the program.

Potential impact: The investigators believe that this program has a potential to be a viable tool in promoting effective and scalable home cooking interventions aimed at improved nutrition and health outcomes in overweight and obesity.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention: Nutritional counseling + CCTP

Nutritional counseling + Culinary Coaching Telemedicine Program (CCTP)

Group Type: ACTIVE_COMPARATOR

CCTP

Intervention Type: BEHAVIORAL

Twelve weekly one-on-one 30-minute tele-sessions through video conference. At the first session, subjects identify their vision regarding home cooking and 3-month goals. During each subsequent meeting, subjects will review their progress towards reaching the prior week's culinary goals and identify goals for the coming week, using a self-discovery process. When patients detect a new culinary skill that is necessary for their progress, s/he will either be taught through discussions or referred to active learning from a Culinary Resource Center.

Nutritional counseling

Intervention Type: BEHAVIORAL

Two 30-minute nutritional counseling sessions

Control: Nutritional counseling only

Two 30-minute nutritional counseling sessions

Group Type: ACTIVE_COMPARATOR

Nutritional counseling

Intervention Type: BEHAVIORAL

Two 30-minute nutritional counseling sessions

Interventions

CCTP

Twelve weekly one-on-one 30-minute tele-sessions through video conference. At the first session, subjects identify their vision regarding home cooking and 3-month goals. During each subsequent meeting, subjects will review their progress towards reaching the prior week's culinary goals and identify goals for the coming week, using a self-discovery process. When patients detect a new culinary skill that is necessary for their progress, s/he will either be taught through discussions or referred to active learning from a Culinary Resource Center.

Intervention Type: BEHAVIORAL

Nutritional counseling

Two 30-minute nutritional counseling sessions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Stable oral medications for the past 3 months (or with type 2 diabetes mellitus who are well controlled (Hga1C<7.5) and on stable oral medications for the past 6 months
• Body mass index (BMI) equal or greater than 27.5 Kg/m2 and equal or lower than 35 Kg/m2.
• Subjects who will agree to be randomized to either one of the 2 study arms
• Accessible by phone, and able to watch online videos.
• English (Spaulding) or Hebrew (Sheba) speaking subjects
• At least self-report one visit with a physician or dietitian in the last 12 months.

Exclusion Criteria

• Pregnant or nursing women within the past 6 months
• Weight loss medications (e.g., topiramate, buproprion, orlistat) within the past 6 months or medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine
• Either type 1 or 2 diabetes who are on insulin
• Uncontrolled hypothyroidism or hyperthyroidism
• Serious medical conditions likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g., end stage renal disease on dialysis, cancer diagnosis or treatment within 2 years)
• Unstable angina or with myocardial infarction, stroke or atherosclerotic cardiovascular disease procedure within 6 months prior to screening
• Self-reported average consumption of > 14 alcoholic drink per week
• Prior or planned bariatric surgery
• Unintentional weight loss within 6 months of enrollment (≥ 5% of body weight), or Intentional weight loss within 6 months (≥ 5% of body weight)
• Subjects following specific dietetic recommendations (e.g., celiac sprue, cystic fibrosis)
• Subjects with eating disorders, or any psychiatric hospitalization in last year prior to screening.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ran Polak

CHEF Coaching program director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rani Polak, MA

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation hospitle

Charlestown, Massachusetts, United States

Sheba Medical Center

Ramat Gan, , Israel

Countries

United States; Israel

Other Identifiers

2018P002115

Identifier Type: -

Identifier Source: org_study_id